Application 065391

Type: ANDA
Sponsor: WOCKHARDT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFTRIAXONE	CEFTRIAXONE SODIUM	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	EQ 250MG BASE/VIAL	No	No
002	CEFTRIAXONE	CEFTRIAXONE SODIUM	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	EQ 500MG BASE/VIAL	No	No
003	CEFTRIAXONE	CEFTRIAXONE SODIUM	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	EQ 2GM BASE/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A065391-001	CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12
A065391-002	CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12
A065391-003	CEFTRIAXONE	CEFTRIAXONE SODIUM	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A065391-001	AP
A065391-002	AP
A065391-003	AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A065391-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065391-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065391-003	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065391-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065391-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065391-003	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065391-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065391-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065391-003	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065391-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065391-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065391-003	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065391-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065391-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065391-003	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065391-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065391-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065391-003	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065391-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065391-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065391-003	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065391-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065391-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065391-003	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065391-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065391-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065391-003	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065391-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065391-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065391-003	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065391-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065391-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065391-003	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065391-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065391-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065391-003	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065391-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065391-002	CEFTRIAXONE	EQ 500MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065391-003	CEFTRIAXONE	EQ 2GM BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065391-001	CEFTRIAXONE	EQ 250MG BASE/VIAL	INJECTABLE / INTRAMUSCULAR, INTRAVENOUS	AP	2007-04-12	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A065391-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065391-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065391-003	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065391-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065391-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065391-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065391-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065391-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065391-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065391-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065391-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065391-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065391-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065391-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065391-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065391-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065391-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065391-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065391-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065391-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065391-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065391-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065391-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065391-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065391-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065391-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065391-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065391-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065391-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065391-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065391-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065391-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065391-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065391-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065391-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065391-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065391-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065391-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065391-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065391-001	AP	1	`301d65b070ca…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 2 · 34 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	A-S Medication Solutions	1aa0a4ee-1b39-4c3d-a7a3-33dded6fe28c	2024-01-31	Warnings, Adverse reactions	Name fallback generic name: CEFTRIAXONE SODIUM
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	A-S Medication Solutions	ff8e830a-c288-46fb-9e19-ec2017943c07	2024-01-31	Warnings, Adverse reactions	Name fallback generic name: CEFTRIAXONE SODIUM
ceftriaxone	CEFTRIAXONE	Sagent Pharmaceuticals	5cf93bc5-9e4c-4734-bc02-c7d0ac071022	2023-11-08	Warnings, Adverse reactions	Name fallback brand name: ceftriaxone
Ceftriaxone	CEFTRIAXONE	Fresenius Kabi USA, LLC	7ea1db43-40fa-417b-8911-ae98092070a0	2023-09-30	Warnings, Adverse reactions	Name fallback brand name: Ceftriaxone
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Asclemed USA, Inc.	f01cf0e5-caaf-4759-ba21-50f3aceff523	2023-09-02	Warnings, Adverse reactions	Name fallback generic name: CEFTRIAXONE SODIUM
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Apotex Corp.	5116231f-82d1-44be-b08e-560c9a50e5c5	2023-08-31	Warnings, Adverse reactions	Name fallback generic name: CEFTRIAXONE SODIUM
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Apotex Corp.	ac03a72c-0e35-40f9-b7fc-081badb5f19c	2023-01-28	Warnings, Adverse reactions	Name fallback generic name: CEFTRIAXONE SODIUM
Ceftriaxone	CEFTRIAXONE SODIUM	Samson Medical Technologies, LLC	5cd2d96f-83e5-4326-ae87-d0ede4ba493a	2023-01-15	Warnings, Adverse reactions	Name fallback brand name: Ceftriaxone generic name: CEFTRIAXONE SODIUM
Ceftriaxone	CEFTRIAXONE	Proficient Rx LP	fcf401df-bcdc-4773-a63b-9741c0f74b3d	2022-11-01	Warnings, Adverse reactions	Name fallback brand name: Ceftriaxone
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Proficient Rx LP	a25ab5ea-c46d-4562-8f7e-0ccffc2ab069	2022-10-01	Warnings, Adverse reactions	Name fallback generic name: CEFTRIAXONE SODIUM
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Proficient Rx LP	42ba7a9d-7d2b-4eac-af59-897151a8c924	2022-05-02	Warnings, Adverse reactions	Name fallback generic name: CEFTRIAXONE SODIUM
Ceftriaxone Sodium	CEFTRIAXONE SODIUM	Hospira, Inc	9d1f630b-e759-4395-9d01-ddc90e4fea75	2022-03-09	Warnings, Adverse reactions	Name fallback generic name: CEFTRIAXONE SODIUM
Ceftriaxone	CEFTRIAXONE	Hikma Pharmaceuticals USA Inc.	8351aa37-552d-471d-b293-c564dcb6ec29	2021-12-01	Warnings, Adverse reactions	Name fallback brand name: Ceftriaxone
Ceftriaxone	CEFTRIAXONE	Hikma Pharmaceuticals USA Inc.	1f8776bd-4f5b-427a-849a-6b8338f7997d	2019-04-24	Warnings, Adverse reactions	Name fallback brand name: Ceftriaxone

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42254-152	CEFTRIAXONE	CEFTRIAXONE	Rebel Distributors Corp	ANDA	Current
42254-191	CEFTRIAXONE	CEFTRIAXONE	Rebel Distributors Corp	ANDA	Current
55648-701	CEFTRIAXONE	CEFTRIAXONE	Wockhardt Limited	ANDA	Current
55648-702	CEFTRIAXONE	CEFTRIAXONE	Wockhardt Limited	ANDA	Current
55648-703	CEFTRIAXONE	CEFTRIAXONE	Wockhardt Limited	ANDA	Current
64679-701	CEFTRIAXONE	CEFTRIAXONE	Wockhardt USA LLC.	ANDA	Current
64679-701	CEFTRIAXONE	CEFTRIAXONE	Wockhardt USA LLC.	ANDA	Current
64679-701	CEFTRIAXONE	CEFTRIAXONE	Wockhardt USA LLC.	ANDA	Current
64679-702	CEFTRIAXONE	CEFTRIAXONE	Wockhardt USA LLC.	ANDA	Current
64679-702	CEFTRIAXONE	CEFTRIAXONE	Wockhardt USA LLC.	ANDA	Current
64679-702	CEFTRIAXONE	CEFTRIAXONE	Wockhardt USA LLC.	ANDA	Current
64679-703	CEFTRIAXONE	CEFTRIAXONE	Wockhardt USA LLC.	ANDA	Current
64679-703	CEFTRIAXONE	CEFTRIAXONE	Wockhardt USA LLC.	ANDA	Current
64679-703	CEFTRIAXONE	CEFTRIAXONE	Wockhardt USA LLC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44236	ORIG	2008-09-19